Avid Bioservices Inc (CDMO)

[Fire Fox]

Both new trials are "OPEN LABEL." I am surprised there hasn't been more discussion of this point in yesterday's PR. Two separate points:

First, "open label" means that SK will be able to know and use results from these two new trials to leverage his BP partnership talks starting when the first 30-40 patients have been treated.

You can be sure BMY will know results from the first 3 lung patients treated at MSK with combo Bavi plus Opdivo even before SK gets those results.

Second, the fact that the Company can specify in a PR that the Phase II/III breast trial will be "open label" means that Garnick is already well advanced in his discussions with the FDA. IMO, Garnick would only get a green light from the FDA to do an open label Phase III study because the FDA is looking at Bavi favorably, has seen the same data that led MSK to collaborate on Bavi, and is ready to accelerate Bavi's approval track in other indications, both as a drug that is safe and makes chemo better, and as a drug that is safe and makes anti-PD-1 better.

"Open label" for both trials means things are lined up now to move very fast, both at the BP level and the FDA level.

Do others agree?